Ireland
--:--IST
Recruiting Not applicable

Clinical and Electromyographic Assessment of Occlusal Splint Therapy

NCT07878247 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2026-10-16

Condition(s) studied

Temporomandibular Joint Disorders

Investigational drug(s) / intervention(s)

Low Level Laser Therapy

Low Level Laser Therapy: to evaluate the treatment of Tempromandibular Joint disorders by low-level laser therapy with occlusal splint treatment or occlusal splint therapy alone in reducing pain intensity and improving masticatory muscle activity, as assessed clinically and electromyographically.

Study summary

Temporomandibular disorders (TMDs) cause pain and dysfunction in the masticatory system, often managed with occlusal splint therapy. However, splint therapy alone may yield inconsistent results. Low-level laser therapy (LLLT) has been proposed as an adjunctive treatment to enhance pain relief and muscle function through photo biomodulation. Evidence comparing the efficacy of splint therapy alone versus its combination with LLLT remains limited. This study aims to evaluate, clinically and electromyographically.

The evidence for occlusal splints is mixed: some systematic reviews report possible short-term benefits for muscle pain but overall the evidence is inconclusive and of variable quality. Low-level laser therapy (LLLT) has been studied for TMD and orofacial pain with several systematic reviews and meta-analyses showing potential analgesic and anti-inflammatory effects, though study heterogeneity exists.

EMG will be used for measurement of muscle activity before and after occlusal splint and low level laser in patients with pain in TMJ.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Patients who had a Diagnosis of TMD, with chronic pain, muscle spasms, myofascial pain syndrome lasts at least 3 months, and challenges while chewing * Patients who have Bruxism Exclusion Criteria: * Patients with a history of trauma, fracture, or surgery involving the temporomandibular joint. * Presence of systemic or neuromuscular diseases (e.g., rheumatoid arthritis, fibromyalgia, Parkinson's disease). * Ongoing orthodontic treatment or recent prosthodontic rehabilitation affecting occlusion. * Use of analgesics, muscle relaxants, or anti-inflammatory drugs within two weeks before the study. * Pregnant or lactating women. * Poor compliance or inability to attend follow-up visits.

Primary outcome measure(s)

  • Treatment of Tempromandibular joint Pain — 3 months
    Treatment of pain resulting from Tempromandibular joint disorders by Occlusal splints in combination with low level laser therapy assessed by Visual Analog Scale (VAS) from 0 to10 where 0 is the worse while the 10 is the best results

Trial sites (1)

FacilityCityRegionStatus
Future University in Egypt (FUE) Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07878247 on ClinicalTrials.gov ↗ ← All trials in Egypt